LAURIMED POLYPVAC MICRODEBRIDER

K133133 · Laurimed, LLC · ERL · Dec 23, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K133133
• Device Name: LAURIMED POLYPVAC MICRODEBRIDER
• Applicant: Laurimed, LLC
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Dec 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

Device Story

The Laurimed PolypVac Microdebrider is a single-use, sterile, hand-held surgical instrument designed for cutting and aspirating polyp tissue during nasal and sinus procedures. The device features a 3.5 mm shaver blade with a rounded tip and a side-facing cutting window with serrated edges. It operates by connecting to a user-supplied vacuum pump and irrigant source; the vacuum draws polyp tissue into the cutting window where it is incised by the blade. The device is manually positioned by a surgeon under endoscopic guidance and activated via a hand-piece trigger. It is intended for use by ENT surgeons in a clinical or surgical setting. By providing a dedicated, disposable tool for tissue resection, the device facilitates the removal of polyps while minimizing the risk of cross-contamination associated with reusable instruments. The inclusion of a low-speed motor and specific blade geometry aims to improve surgical control and reduce clogging during the procedure.

Clinical Evidence

No human clinical data. Evidence consists of in-vitro bench testing and cadaver model studies. Bench testing compared aspiration rates and clogging frequency against the predicate using simulated polyp tissue; results showed non-inferiority and a trend toward reduced clogging. Cadaver study involved three board-certified ENT surgeons performing polypectomies; results demonstrated non-inferiority in the degree of complete polyp removal (grams of unresected tissue) and similar post-resection site grading by blinded reviewers.

Technological Characteristics

Single-use, sterile, hand-held microdebrider. Materials: Stainless steel blade/window. Dimensions: 3.5 mm outer diameter, 12 cm shaft length. Mechanism: Vacuum-assisted mechanical cutting with side-facing window. Energy: Electric motor (low-speed). Connectivity: Connects to external vacuum pump and irrigant source. Sterilization: E-beam radiation. Interface: Hand-piece trigger activation.

Indications for Use

Indicated for the excision of polyps in the nasal passageways and sinuses where access is established.

Regulatory Classification

Identification

An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

Predicate Devices

• Medtronic Xomed, Inc., XPS 3000 System (K041413)

Submission Summary (Full Text)

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### Laurimed LLC

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### A. Name, Address, Phone and Fax Number of Applicant

Laurimed LLC 500 Arguello Street, Suite 100 Redwood City, CA 94063 Phone: [phone] [phone] Fax:

#### B. Contact Person

Nancy Lincé, RAC Regulatory Affairs Consultant Lincé Consulting Phone: [phone] [e-mail]

Alternate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant [phone] [e-mail]

#### C. Date Prepared

September 27, 2013

### Device Name D.

| Trade Name: | Laurimed PolypVac Microdebrider |
|----------------------|---------------------------------------------------|
| Common Name: | Microdebrider |
| Classification Name: | Ear, nose, and throat electric or pneumatic drill |

#### E. Device Classification

| Classification: | 21 CFR §874.4250 |
|-----------------|------------------|
| Product Code: | ERL |
| Device Class: | Class II |

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#### F. Predicate Devices

The Laurimed PolypVac Microdebrider is substantially equivalent to the Medtronic Xomed, Inc., XPS 3000 System (K041413).

#### G. Device Description

The Laurimed PolypVac Microdebrider is intended for cutting and aspirating polyp tissue during sinus and nasal procedures. The system consists of a hand-held cutting device and device cleaner.

The PolypVac Microdebrider is supplied sterile and is single-use and disposable.

#### H. Intended Use

Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

#### 1. Technological Comparison

The Laurimed PolypVac Microdebrider has similar features as compared to the predicate devices in the table below.

| Manufacturer | Medtronic Xomed, Inc. | Laurimed LLC | |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--|
| Model Name | XPS 3000 System<br>(with RAD12 & RAD40 shaver blades) | PolypVac Microdebrider | |
| 510(k) Number | K041413 | TBD | |
| Indications for Use | Intended for the incision and removal of<br>soft and hard tissue or bone in general<br>otorhinolaryngology, head and neck, and<br>otoneurological surgery.<br>Sinus Indications include septoplasty,<br>removal of septal spurs, polypectomy,<br>antrostromy.<br>ethmoidectomy/specnoethmoidectorny,<br>frontal sinus trephination and irrigation,<br>frontal sinus drill out, endoscopic DCR,<br>trans-spheniodal procedures, maxillary<br>sinus polypectomy, circumferential<br>maxillary antrostomy, choanal atresia,<br>sphenoidotomy, and medial, lateral, and<br>posterior frontal sinusotomy | Indicated for the excision of polyps in the<br>nasal passageways and in sinuses for<br>which access has been previously<br>established. | |
| Product Code | ERL | Same | |
| Manufacturer | Medtronic Xomed, Inc. | Laurimed LLC | |
| Model Name | XPS 3000 System<br>(with RAD12 & RAD40 shaver blades). | PolypVac Microdebrider | |
| 510(k) Number | K041413 | TBD | |
| Mechanics of<br>Action | Cutting elements moving inside an open<br>window with suction | Same | |
| Anatomical sites | Head, neck, ear, nose (including the<br>sinuses), and throat | Nose (including sinuses) | |
| Design Features | 3.5 mm Shaver Blade<br>Rounded tip<br>Side-facing cutting window with<br>serrated edges<br>Fixed curves<br>Rotatable<br>Hand-piece<br>Houses electrical motor<br>Foot-switch activated<br>Proximal end attaches to user-<br>supplied vacuum and irrigant<br>sources<br>Console<br>Electrical power source | 3.5 mm Shaver Blade<br>Rounded tip<br>Side-facing cutting window with<br>serrated edge<br> | |
| Mechanism of<br>Action | User-supplied vacuum pump draws polyp<br>tissue into side-facing cutting window,<br>tissue incised by blade | User-supplied vacuum pump draws polyp<br>tissue into side-facing cutting window,<br>tissue incised by blade | |
| Components | Hand-piece<br>Removable Distal Shaft with Cutting<br>Element<br>Device Cleaner<br>Console & Footswitch | Hand-piece with Integrated Distal Shaft<br>with Cutting Element<br>Device Cleaner | |
| Safety Features | Blunt Tip, Side-Cutting Window, Activation<br>switch | Same, with the addition of a low-speed<br>motor | |
| Sterile Packaging | Tyvek/Mylar Pouch for sterile / disposable<br>distal shafts | Same | |
| Sterilization<br>Method<br>External Device<br>Compatibility | Ethylene Oxide (EtO) for sterile /<br>disposable distal shafts<br>Endoscope<br>Vacuum pump<br>Sterile Irrigant bag<br>Collection Canister | E-beam radiation<br>Endoscope<br>Vacuum pump<br>Sterile Irrigant syringe or bag | |
| Biocompatible for<br>Intended Use | Yes | Same | |
| Blade / window<br>material | Stainless Steel | Same | |
| Shaft Outer<br>Diameter | 3.5 mm (RAD 12 & 40 blades) | 3.5 mm | |
| Shaft Length | 11 cm (RAD 12 & 40 blades) | 12 cm | |
| Angle of Distal Tip<br>User Interface | 12° - 40° (RAD 12 & 40 blades)<br>Activation switch (footswitch) | 0° - 45°<br>Activation switch (hand-piece trigger) | |
| Human Factors | User holds the hand-piece to insert and<br>position device at intended surgical site | Same | |
| Contraindications | None | Same | |
| Method of<br>Introduction | Manual placement under endoscopic<br>guidance | Same | |
| Function. | Device is positioned at intended site and<br>switch activated to begin resection. | Same | |

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The technological characteristics and principals of operation of the Laurimed PolypVac Microdebrider are substantially equivalent to the noted predicate device.

#### J. Summary of Non-Clinical Data

The Laurimed PolypVac Microdebrider performance characteristics were evaluated in the following in-vitro bench studies:

- . Dimensional Verification Testing
- . Tensile Testing
- . Flow Rate Testing
- . Device Durability
- . Shaft Malieability and Durability
- . Bench Top Performance*
- . Leakage & Syringe Compatibility
- . Cadaver Predicate Comparison **
- . Biocompatibility Testing
- o Cytotoxicity
- o Sensitization
- o Irritation
- . Sterilization Validation
- . Packaging Validation
- Shelf Life .

# *Bench-top Performance Testing

Bench Top Performance Testing using the PolypVac Microdebrider and the Xomed XPS 3000 with RAD40 blades was completed to compare the aspiration rate performance of the subject and predicate device using simulated polyp tissue models. Non-inferiority was demonstrated based on resection rates in two sample tissue models. Data collected on clogging trended in favor of the PolypVac Microdebrider, where the device clogged less frequently than the Xomed XPS 3000 blades. Therefore, the results of this testing demonstrate that the PolypVac Microdebrider is substantially equivalent to the Xomed predicate in terms of aspiration rates in simulated polyp tissue models representing the spectrum of human polypoid tissue.

## **Cadaver Predicate Comparison Testing

Cadaver Predicate Comparison testing using the PolypVac Microdebrider and the Xomed XPS 3000 with RAD12 and RAD40 blades was completed to compare the performance when used by three (3) independent board-certified ENT surgeons to excise simulated attached sinonasal polyps from worst-case accessible locations in a cadaver model. Non-inferiority was demonstrated based on the degree of complete polyp removal (as measured by grams of unresected tissue). Post-resection images of the attachment site were graded by a blinded reviewer and found to be similar for the PolypVac Microdebrider (average: 1.08) and Xomed XPS 3000 (average: 1.00). Therefore, the results of this testing demonstrate that the PolypVac Microdebrider is substantially equivalent to the Xomed predicate when used to navigate to and resect worst-case polyps during simulated polypectomy procedures in a cadaver model.

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Results of the non-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the Laurimed PolypVac Microdebrider meet the established specifications necessary for consistent performance during its intended use. This testing demonstrates the Laurimed PolypVac Microdebrider is safe and is substantially equivalent to the named predicate.

#### K. Summary of Data

The Laurimed PolypVac Microdebrider has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. In addition, non-clinical testing, including comparative testing, was conducted to validate the performance of the device and ensure the Laurimed PolypVac Microdebrider functions as intended and meets design specifications. The comparison and non-clinical performance testing results demonstrate that the Laurimed PolypVac Microdebrider is substantially equivalent to the predicate device for its intended use and does not raise new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized emblem with three curved lines resembling a person with outstretched arms. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.

December 23, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Laurimed, LLC % Ms. Nancy Lincé, RAC Lincé Consulting 8 Crow Canyon Court, Suite 205 San Ramon, CA 94583

Re: K133133

Trade/Device Name: PolypVac Microdebrider Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Received: September 27, 2013 Dated: September 30, 2013

Dear Ms. Lincé:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Ms. Nancy Lincé

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Tina Kiang -S 2013.12.23 15:54:36 -05'00' for Malvina B. Eydelman, M.D.

Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Laurimed LLC | Traditional 510(k) Notification<br>PolypVac Microdebrider |
|--------------|-----------------------------------------------------------|
|--------------|-----------------------------------------------------------|

Indications for Use Statement

| 510(k) Number (If known): | K133133 |
|---------------------------|------------------------|
| Device Name: | PolypVac Microdebrider |

Indications for Use:

Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

| Prescription Use | X | Or<br>(per 21 CFR 801.109) | Over-The-Counter Use |
|------------------|---|----------------------------|----------------------|
|------------------|---|----------------------------|----------------------|

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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